AzTrials
AzTrials

Pain, PostoperativeSPARCNCT03137732

Surgical Versus Anaesthetic Placement of Rectus Sheath Catheters

A study testing Rectus Sheath Catheter in people with Pain, Postoperative and Wound; Abdomen, run by Countess of Chester NHS Foundation Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative, Wound; Abdomen, Incision
What is being tested?
Rectus Sheath Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Jun 2017to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged over 18 years
  • Able to provide informed consent
  • Undergoing elective, open colorectal surgery or emergency laparotomy via a midline incision extending above the umbilicus
  • Weight of 50kg or over to standardise the analgesia given.

Who cannot join

  • Weight of less than 50kg
  • Patients unable to consent
  • Age under 18 years
  • Inability to insert RSC - local infection or severe coagulopathy
  • Allergy to local anaesthetic
  • Chronic pre-operative use of strong opioids or gabapentins and or chronic pain syndromes

Trial locations and contacts

No sites are listed yet.

Dale Vimalachandran, MBChB MD FRCS contact

01244 365000

dale.vimalachandran@nhs.net

Elizabeth G Kane, MBChB BSc MRCS contact

ekane1@nhs.net

About this study

Official title: Surgical Placement Versus Anaesthetic Placement of Rectus Sheath Catheter for Pain Relief Following Major Abdominal Surgery (SPARC). A Single Centre Randomised Controlled Trial

This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery.

Read the detailed description

Background and study aims Pain management post laparotomy (abdominal surgery) can be difficult and in our trust we are increasingly using rectus sheath catheters (RSCs).This is achieved by placing catheters, done by either by the surgeon or anaesthetist into the potential space between the rectus muscle and the posterior rectus sheath. Two catheters are placed, one on either side of the mid-line wound. Local anaesthetic is then infused through the catheters for up to 3 days post-operatively. This provides analgesia to the central abdominal wall in the region of the T7-T11 dermatomes. It only provides analgesia for somatic pain, not visceral pain and hence needs to be used in addition to a multi-modal analgesic regime usually including a patient controlled analgesia device (PCA) containing either morphine or oxycodone. Advantages of a RSC infusion over an epidural include that it can be used in patients with coagulopathy or systemic infection and can be safely performed asleep. It is also less labour intensive to manage on the ward and does not carry the same risks of hypotension and excessive fluid administration that are associated with an epidural.

There is randomised controlled trial evidence that RSC infusions in addition to PCA provide superior analgesia when compared to PCA alone in surgery performed through a midline incision. There is also a randomised controlled trial in progress that is comparing analgesic quality of epidural infusions to RSC with PCA. In most published literature to date, RSC are inserted by the anaesthetist using ultrasound to aid placement. In our hospital, some RSC are inserted by anaesthetists although the majority are performed by surgeons at the end of an operation. This is because we believe that this technique is less time consuming and both insertion techniques result in equivalent analgesia.

The primary aim endpoint of this study is to determine any difference in insertion time for rectus sheath catheters between those inserted by surgeons and those inserted by anaesthetists. Observationally in our hospital, there is no difference in quality of analgesia provided by the two insertion techniques. However, surgical insertion of RSC causes less disruption of an operation as the patient already has their abdomen draped with sterilised skin as part of their surgical procedure. Also, surgical insertion of RSC with an open abdomen is potentially easier than ultrasound guided insertion by an anaesthetist before an operation.

Who can participate? Any adults undergoing emergency or elective laparotomy (major abdominal surgery.) What does the study involve? All participants will receive rectus sheath catheters but will be randomly allocated to each group. Following the surgery, participants will have to answer questions about their pain on 3 consecutive days.

What are the possible benefits and risks of participating? There are no specific benefits to patients and the risks are the same if they were in the trial or not as it is routine in our hospital to use rectus sheath catheters as a means of analgesia post laparotomy. These risks include bleeding, dislodgement of catheter and failure of catheter and are low risk.

Where is the study run from? This a single centre study at the Countess of Chester Hospital in the United Kingdom.

When is study starting and how long is it expected to run for? We anticipate recruiting patient from June 2017 for 6 months. How long will the trial be recruiting participants for? No funding is required as all data collection will be carried out by doctors working in the departments but the study is being supported and supervised by the Hospital's Research and Development department.

Being tested
Rectus Sheath Catheter
Medical subject headings
Pain, Postoperative, Abdominal Injuries, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rectus Sheath CatheterDevice

    Insertion of rectus sheath catheter via either method

Study groups in NCT03137732
Study groupRoleWhat they receive
Surgeon-insertedActive comparatorRectus sheath catheter will be inserted under direct vision / palpation of the space at the end of the operation.
Receives: Device: Rectus Sheath Catheter
Anaesthetist-insertedActive comparatorRectus sheath catheter will be inserted under ultrasound guidance by the anaethetist.
Receives: Device: Rectus Sheath Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time taken to insert rectus sheath catheters

    This will be recorded in theatre on a stopwatch and recorded.

    Measured: under 15 minutes

Secondary outcomes (6)
  1. Pain scores

    Patients will be asked to score their pain in recovery and on days 0,1,2,3 post operatively. This will be graded using a Numeric Pain Rating Scale.

    Measured: 4 days

  2. Peri-operative analgesic use

    Analgesic use intra-operatively and post-operatively for 3 days. This will include strong opioids, paracetamol, NSAIDs, codeine, ketamine, IV lignocaine, tramadol, clonidine and PCA usage post-operatively.

    Measured: 4 days

  3. Catheter issues

    This includes haemorrhage, dislodgement, blockage

    Measured: 4 days

  4. Duration of catheter use

    Measured: 4 days

  5. TIme to diet and mobilisation

    Measured: likely 1-3 days

  6. Time to discharge

    Measured: approximately 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study startJun 2017 (estimated)
  3. Primary completionDec 2017 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03137732
Sponsor's protocol ID
Surg 058/17
Acronym
SPARC
Status last verified
Apr 2017
First submitted
26 Apr 2017
Last updated
3 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Rectus Sheath Catheter in people with Pain, Postoperative and Wound; Abdomen, run by Countess of Chester NHS Foundation Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dale Vimalachandran, MBChB MD FRCS (01244 365000, dale.vimalachandran@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time taken to insert rectus sheath catheters (time frame: under 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in